CDSCO Checklist – Medical Device Application Forms
The CDSCO Checklist helps manufacturers identify the correct MD forms for medical device applications in India. This CDSCO Checklist simplifies the process of selecting forms, understanding requirements, and using the Sugam Portal for submission.
The CDSCO Checklist covers key MD forms used for manufacturing, import, test licenses, and clinical investigations under CDSCO regulations.
Key MD Forms
- MD-3 / MD-4: Manufacturing or loan license for Class A & B devices
- MD-7 / MD-8: Manufacturing or loan license for Class C & D devices
- MD-12: Test license for manufacturing (clinical/testing purposes)
- MD-14: Import license for medical devices
- MD-16: Test license for import
- MD-22: Clinical investigation approval
Common Requirements
The CDSCO Checklist includes:
- Cover letter and firm constitution documents
- Plant Master File & Device Master File
- QMS (ISO 13485) and regulatory approvals
- Risk management and safety data
- Clinical investigation documents (if applicable)
- Labeling, agreements, and undertaking declarations
Using the CDSCO Checklist ensures accurate form selection, proper documentation, and faster approval for medical device applications in India.